Status:
COMPLETED
Safety And Efficacy Of Empagliflozin In Pakistani Muslim Population With Type Ii Diabetes Mellitus
Lead Sponsor:
Getz Pharma
Conditions:
Type II Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To compare the safety and efficacy of empagliflozin versus other treatments in Pakistani Muslim population with type II diabetes mellitus.
Detailed Description
Diabetes is the one of the most common non-communicable diseases affecting 425 million adults worldwide. This figure is expected to rise to 629 million by the year 2045.1 90% of the diabetic populatio...
Eligibility Criteria
Inclusion
- Pakistani muslim male / female, type 2 diabetic patient having age from 18 years to 75 years
- Patient who give informed consent voluntarily
- BMI ≤45 kg/m2
- Glycosylated hemoglobin of 7 - ≤10%
Exclusion
- Patients who are on empagliflozin treatment
- Indication of liver disease, defined by serum levels of either alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase above 3 times upper limit to normal
- Estimated glomerular filtration rate (eGFR) \<45 mL /min /1.73m2
- History of recurrent urinary tract infection (UTI) and/or past 3 months' history of UTI and its treatment
- Patients with positive urine culture for UTI at the time of screening
- Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state
- Patients with past 3 months' history of fungal infection and its treatment
- History of blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
- History of benign prostate hyperplasia
- Any acute coronary syndrome, stroke and/or transient ischemic attack (TIA) in the previous 3 months
- Any contraindication for patients to Biguanides, Sulfonylureas, DPP-IV inhibitors, SGLT-2 Inhibitors
- Treatment with anti-obesity drugs or any other treatment leading to unstable body weight
- Patients with past 6 weeks treatment history with systemic steroids or thyroid hormones or any other uncontrolled endocrine disorder except T2DM
- Pre-menopausal women who are nursing or pregnant or are of childbearing potential and not practicing an acceptable method of birth control
- Any other clinical condition that would jeopardize patients safety while participating in this study
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2020
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT04665284
Start Date
June 1 2019
End Date
September 28 2020
Last Update
December 11 2020
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Balochistan Medical Center
Quetta, Balochistan, Pakistan
2
Lady Reading Hospital
Peshawar, Khyber Pakhtunkhwa, Pakistan
3
Post Graduate Medical Institute
Peshawar, Khyber Pakhtunkhwa, Pakistan
4
Hanif Medical Center
Islamabad, Punjab Province, Pakistan